Anorexia NervosaDIAMOnDSNCT06043154
Discovering New Insights Into Anorexia Nervosa: Influence of MicrObial DysbiosiS (DIAMOnDS)
A study testing Patients with severe to extreme anorexia nervosa admitted to hospital for refeeding in people with Anorexia Nervosa, run by Nantes University Hospital at 1 site in France.
Trial summary
This study will investigate the link between the gut microbiota, the occurrence of the central adiposity phenotype, and the patients' fear to regain weight in anorexia nervosa. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Patients with severe to extreme anorexia nervosa admitted to hospital for refeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2024to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women
- Over 15 years old and 3 months.
- Admitted in the specialized department for eating disorders of CHU Nantes for refeeding.
- With a diagnosis of anorexia nervosa at admission (restrictive or Binge-Eating-Purging type).
- Body Mass Index at admission below 16 kilogram per square meter.
- Written informed consent for patients over 18 years old/ oral informed consent from both the patient and a legal representative for patients under 18 years old.
- Affiliated with French social security system or beneficiary from such system.
Who cannot join
- Pregnant and breastfeeding women.
- Who received a treatment with antibiotic/antifungal (other than local application) in the last three months.
- Who had a weight gain in the last month (5% or more of the patient's weight at admission).
- Under trusteeship or guardianship.
- Not fluent in French
- Who participate in another interventional study involving medication.
- Patients for whom stool collection or body mass composition analysis (with Dual-energy X-ray absorptiometry) couldn't be done during the first week of hospitalisation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, 44093
Marie GRALL-BRONNEC, Professor, +33 2 40 84 76 20, marie.bronnec@chu-nantes.fr
About this study
This study will investigate the link between the gut microbiota, the occurrence of the central adiposity phenotype, and the patients' fear to regain weight in anorexia nervosa.
Read the detailed description
Excessive concerns about body shape and intense fear of becoming fat are among the core features of Anorexia Nervosa (AN). During refeeding, patients commonly report a disproportionate deposition of fat in the abdomen which could represent an obstacle for weight gain. It is not known whether these complaints are caused by dysmorphophobia or if the distribution of fat during refeeding could really not be uniform. Indeed, a "central adiposity phenotype" has already been objectified by anthropometric measures or imaging, with a higher proportion of visceral fat accumulated in the abdomen during the refeeding. This phenomenon could exacerbate body shape concerns and ultimately lead to an elevated risk of resistance to treatment and/or relapse.
The present research project aims to explore the mechanisms that underlie these difficulties, especially by investigating the link between the gut microbiota (both composition and products) and the occurrence of the central adiposity phenotype, and the patients' fear to regain weight.
Patients with severe to extreme anorexia nervosa admitted at hospital for refeeding will be included.
To describe patients included, a short clinical examination will be performed during the first week after inclusion, including several measures (sociodemographic data, medical history, history of eating disorders, current symptomatology of AN, and a dietary survey).
To investigate the gut microbiota biomarkers in stool (composition, diversity and richness, and metabolites), stool samples will be collected during the first week after inclusion and during the last week before discharge, together with information useful to stool sample analyses (related to stool consistency, intestinal transit, abdominal pain or discomfort, and psychoactive substance and prebiotics use).
In addition, blood samples will be collected during the first week after inclusion and during the last week before discharge, to investigate : (i) the levels of metabolites of the gut microbiota in blood, (ii) the nutritional and inflammation status.
To investigate central adiposity phenotype, anthropometric data will be collected weekly throughout the hospitalisation (including during the first and last week), and dual-energy X-ray absorptiometry (DXA) will be administered during the first week after inclusion and during the last week before discharge.
To investigate clinical outcomes, several self-reported questionnaires will be completed by the patients during the first week after inclusion and during the last week before discharge, including cognitive and behavioral characteristics of AN, body shape concerns, level of physical hyperactivity, anxiety and depression. Moreover, treatment-related data, hormonal situation and eating disorder episodes will be collected during weekly follow-up visits. Finally, a short clinical examination will be performed during the last week before discharge to collect the whole duration of hospitalisation and the current symptomatology of eating disorders.
This will allow to compare gut microbiota biomarkers (composition, diversity and richness, and metabolites) between patients with and without occurrence of the central adiposity phenotype during refeeding, to estimate the frequency of the occurrence of the central adiposity phenotype during refeeding, to characterise the gut microbiota biomarkers of patients with severe to extreme anorexia nervosa, to investigate the association between the occurrence of the central adiposity phenotype during the refeeding and clinical outcomes of the hospitalisation, to identify the gut microbiota biomarkers associated with clinical outcomes of the hospitalisation, and to estimate a mediation model to explain the links between the gut microbiota biomarkers and clinical outcomes, through the occurrence of the central adiposity phenotype and the change in body shape concerns..
An ancillary study will also be perfomed for patients participating to the DIAMOnDS study and accepting to participate to this ancillary study aimed at investigating the association between microbial and metabolic biomarkers of the gut microbiota (data collected in the DIAMOnDS study) and osteoporosis at inclusion.
- Conditions
- Anorexia Nervosa
- Being tested
- Patients with severe to extreme anorexia nervosa admitted to hospital for refeeding
- Keywords
- microbiota, dysbiosis
- Medical subject headings
- Anorexia Nervosa, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with severe to extreme anorexia nervosa admitted to hospital for refeedingOther
Also called Clinical and biological measurements, blood and stool sample collection
Clinical and biological measurements, blood and stool sample collection
| Study group | Role | What they receive |
|---|---|---|
| Anorexia nervosa | Experimental | Not described Receives: Other: Patients with severe to extreme anorexia nervosa admitted to hospital for refeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of gut microbiota biomarkers - composition
Species-level taxonomic profile and functional potential of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion, between those who express or not the central adiposity phenotype.
Measured: At inclusion
Identification of gut microbiota biomarkers - diversity and richness
α-diversity, β-diversity, richness in genes, richness in species and enterotype of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion, between those who express or not the central adiposity phenotype
Measured: At inclusion
Identification of gut microbiota biomarkers - metabolites
Levels of Short Chain Fatty Acids (SCFAs) (acetate, propionate, butyrate, valerate, isobutyrate and isovalerate) produced by the gut microbiota estimated through gas chromatography-mass spectrometry on blood and stool samples collected at inclusion, between those who express or not the central adiposity phenotype.
Measured: At inclusion
Secondary outcomes (7)
Identification of the central adiposity phenotype
Proportion of patients who respond to the definition of the central adiposity phenotype during the refeeding. (The definition of the central adiposity phenotype will be characterised quantitatively through repeated measures of anthropometric data throughout the hospitalisation (waist-hip ratio (WHR), triceps skin fold, body mass index (BMI) and percentage from target weight) and qualitatively through Dual-energy X-ray Absorptiometry (DXA) imaging (repartition in body segment, relative proportion of lean and fat tissues, of subcutaneous and visceral fat mass, and of android and gynoid fat mass)).
Measured: At inclusion
Characterisation of gut microbiota biomarkers of patients with severe to extreme anorexia nervosa - composition
species-level taxonomic profile and functional potential of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion
Measured: At inclusion
Characterisation of gut microbiota biomarkers of patients with severe to extreme anorexia nervosa - diversity and richness
α-diversity, β-diversity, richness in genes, richness in species and enterotype of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion
Measured: At inclusion
Characterisation of gut microbiota biomarkers of patients with severe to extreme anorexia nervosa - metabolites
levels of Short Chain Fatty Acids (SCFAs) (acetate, propionate, butyrate, valerate, isobutyrate and isovalerate) produced by the gut microbiota estimated through gas chromatography-mass spectrometry on blood and stool samples collected at inclusion
Measured: At inclusion
Variation of the composition of the gut microbiota between admission and discharge
Change in the species-level taxonomic profile and functional potential of the gut microbiota generated by shotgun metagenomics, between stool samples collected at inclusion and at discharge
Measured: At discharge, anticipated average 10 weeks
Variation of the diversity and richness of the gut microbiota between admission and discharge
Change in the α-diversity, β-diversity, richness in genes, richness in species and enterotype of the gut microbiota generated by shotgun metagenomics, between stool samples collected at inclusion and at discharge
Measured: At discharge, anticipated average 10 weeks
Variation of the metabolites of the gut microbiota between admission and discharge
Change in the levels of Short Chain Fatty Acids (SCFAs) (acetate, propionate, butyrate, valerate, isobutyrate and isovalerate) produced by the gut microbiota estimated through gas chromatography-mass spectrometry, between stool samples collected at inclusion and at discharge and between blood samples collected at inclusion and at discharge
Measured: At discharge, anticipated average 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start22 Feb 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043154
- Sponsor's protocol ID
- RC21_0598
- Acronym
- DIAMOnDS
- Status last verified
- Nov 2025
- First submitted
- 4 Sep 2023
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovering New Insights Into Anorexia Nervosa: Influence of MicrObial DysbiosiS (DIAMOnDS)
- ClinicalTrials.gov ID
- NCT06043154
- Acronym / sponsor ID
- DIAMOnDS / RC21_0598
- Conditions
- Anorexia Nervosa
- Keywords
- microbiota, dysbiosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Fondation de France
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the link between the gut microbiota, the occurrence of the central adiposity phenotype, and the patients' fear to regain weight in anorexia nervosa.
Detailed description
Excessive concerns about body shape and intense fear of becoming fat are among the core features of Anorexia Nervosa (AN). During refeeding, patients commonly report a disproportionate deposition of fat in the abdomen which could represent an obstacle for weight gain. It is not known whether these complaints are caused by dysmorphophobia or if the distribution of fat during refeeding could really not be uniform. Indeed, a "central adiposity phenotype" has already been objectified by anthropometric measures or imaging, with a higher proportion of visceral fat accumulated in the abdomen during the refeeding. This phenomenon could exacerbate body shape concerns and ultimately lead to an elevated risk of resistance to treatment and/or relapse.
The present research project aims to explore the mechanisms that underlie these difficulties, especially by investigating the link between the gut microbiota (both composition and products) and the occurrence of the central adiposity phenotype, and the patients' fear to regain weight.
Patients with severe to extreme anorexia nervosa admitted at hospital for refeeding will be included.
To describe patients included, a short clinical examination will be performed during the first week after inclusion, including several measures (sociodemographic data, medical history, history of eating disorders, current symptomatology of AN, and a dietary survey).
To investigate the gut microbiota biomarkers in stool (composition, diversity and richness, and metabolites), stool samples will be collected during the first week after inclusion and during the last week before discharge, together with information useful to stool sample analyses (related to stool consistency, intestinal transit, abdominal pain or discomfort, and psychoactive substance and prebiotics use).
In addition, blood samples will be collected during the first week after inclusion and during the last week before discharge, to investigate : (i) the levels of metabolites of the gut microbiota in blood, (ii) the nutritional and inflammation status.
To investigate central adiposity phenotype, anthropometric data will be collected weekly throughout the hospitalisation (including during the first and last week), and dual-energy X-ray absorptiometry (DXA) will be administered during the first week after inclusion and during the last week before discharge.
To investigate clinical outcomes, several self-reported questionnaires will be completed by the patients during the first week after inclusion and during the last week before discharge, including cognitive and behavioral characteristics of AN, body shape concerns, level of physical hyperactivity, anxiety and depression. Moreover, treatment-related data, hormonal situation and eating disorder episodes will be collected during weekly follow-up visits. Finally, a short clinical examination will be performed during the last week before discharge to collect the whole duration of hospitalisation and the current symptomatology of eating disorders.
This will allow to compare gut microbiota biomarkers (composition, diversity and richness, and metabolites) between patients with and without occurrence of the central adiposity phenotype during refeeding, to estimate the frequency of the occurrence of the central adiposity phenotype during refeeding, to characterise the gut microbiota biomarkers of patients with severe to extreme anorexia nervosa, to investigate the association between the occurrence of the central adiposity phenotype during the refeeding and clinical outcomes of the hospitalisation, to identify the gut microbiota biomarkers associated with clinical outcomes of the hospitalisation, and to estimate a mediation model to explain the links between the gut microbiota biomarkers and clinical outcomes, through the occurrence of the central adiposity phenotype and the change in body shape concerns..
An ancillary study will also be perfomed for patients participating to the DIAMOnDS study and accepting to participate to this ancillary study aimed at investigating the association between microbial and metabolic biomarkers of the gut microbiota (data collected in the DIAMOnDS study) and osteoporosis at inclusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anorexia nervosa | Experimental | Other: Patients with severe to extreme anorexia nervosa admitted to hospital for refeeding |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Women
- Over 15 years old and 3 months.
- Admitted in the specialized department for eating disorders of CHU Nantes for refeeding.
- With a diagnosis of anorexia nervosa at admission (restrictive or Binge-Eating-Purging type).
- Body Mass Index at admission below 16 kilogram per square meter.
Key exclusion criteria (7 listed)
- Pregnant and breastfeeding women.
- Who received a treatment with antibiotic/antifungal (other than local application) in the last three months.
- Who had a weight gain in the last month (5% or more of the patient's weight at admission).
- Under trusteeship or guardianship.
- Not fluent in French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with severe to extreme anorexia nervosa admitted to hospital for refeedingAlso: Clinical and biological measurements, blood and stool sample collectionClinical and biological measurements, blood and stool sample collection | Other | Anorexia nervosa |
Primary outcome
Identification of gut microbiota biomarkers - composition
Time frame: At inclusion
Species-level taxonomic profile and functional potential of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion, between those who express or not the central adiposity phenotype.
Identification of gut microbiota biomarkers - diversity and richness
Time frame: At inclusion
α-diversity, β-diversity, richness in genes, richness in species and enterotype of the gut microbiota generated by shotgun metagenomics performed on stool samples collected at inclusion, between those who express or not the central adiposity phenotype
Identification of gut microbiota biomarkers - metabolites
Time frame: At inclusion
Levels of Short Chain Fatty Acids (SCFAs) (acetate, propionate, butyrate, valerate, isobutyrate and isovalerate) produced by the gut microbiota estimated through gas chromatography-mass spectrometry on blood and stool samples collected at inclusion, between those who express or not the central adiposity phenotype.
7 secondary outcomes
Identification of the central adiposity phenotype
Time frame: At inclusion
Characterisation of gut microbiota biomarkers of patients with severe to extreme anorexia nervosa - composition
Time frame: At inclusion
Characterisation of gut microbiota biomarkers of patients with severe to extreme anorexia nervosa - diversity and richness
Time frame: At inclusion
Characterisation of gut microbiota biomarkers of patients with severe to extreme anorexia nervosa - metabolites
Time frame: At inclusion
Variation of the composition of the gut microbiota between admission and discharge
Time frame: At discharge, anticipated average 10 weeks
Variation of the diversity and richness of the gut microbiota between admission and discharge
Time frame: At discharge, anticipated average 10 weeks
Variation of the metabolites of the gut microbiota between admission and discharge
Time frame: At discharge, anticipated average 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients with severe to extreme anorexia nervosa admitted to hospital for refeeding in people with Anorexia Nervosa, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie GRALL-BRONNEC, Professor (+33 2 40 84 76 20, marie.bronnec@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of gut microbiota biomarkers - composition (time frame: At inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.